TysonBio SuperB Скачать руководство пользователя страница 25

■ The TysonBio SUPERB Meter, TysonBio SUPERB Test Strips and Control 

Solution are in conformity with the IVDD 98/79/EC.

The Lancing Device is in conformity with the MDD 93/42/EEC.

■ The Lancets are in conformity with the MDD 93/42/EEC.

Manufacturer:
Tyson Bioresearch, Inc.
5F. #22, Ke E. Road III, Science-Based 
Industrial Park Chu-Nan 350, 
Miao-Li County, Taiwan, R.O.C.
TEL: +886 37 585998

Manufacturer:   
Wuxi Xinda Medical Device Co., Ltd.
No.42 Xixin Road, Zhangjing Town,
Wuxi, Jiangsu,214194,China

Authorized representative in the EU:
EMERGO EUROPE
Molenstraat 15, 2513 BH The Hague, 
The Netherlands

Authorized representative in the EU:    
Medical Device Safety Service GmbH
Schiffgraben 41, D-30175 Hannover,            
Germany
TEL: +49 511 62628630

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Specifications

Operating Conditions:

Hematocrit:

Test Sample:

Sample Volume:

Measuring Range:

Test Time:

Memory Capacity:

Average:

External Output

Power supply:

Battery Life:

Dimension and Weight:

10°C - 40°C(50°F  - 104°F) and 10 - 90% RH

35 - 55%

Capillary Whole Blood from Fingertip, Palm and Forearm

>1.5 

20 - 600 mg/dL (1.1 - 33.3 mmol/L)

10 sec

300 most recent results

7/14/30 days average results

Standard RS232 PC interface

3-Volt lithium battery (CR-2032)

Approximately 1000 tests

102 x50 x15 mm ; 55 g

Содержание SuperB

Страница 1: ...tro diagnostic use only User s Manual Do not reuse Keep dry Keep away from sunlight In Vitro Diagnostics Medical Device Caution consult accompanying documents Read Instructions for use Store at 4 C to...

Страница 2: ...ou or even reaffirm your results Customer Service Hotline 1 800 948 3894 U S 24 hours a day 886 37 585998 our office hours are from 8 30 am GMT0030 5 30 pm GMT0930 or E Mail us at service tysonbio com...

Страница 3: ...ations of the Procedure 47 Service and Warranty 47 Customer Service Important Information 3 Introduction 7 About the Product 8 About the TysonBio SUPERB Meter 9 About the TysonBio SUPERB Meter Display...

Страница 4: ...r taking insulin during exercise or when you are ill or under stress We strongly recommend you do AST ONLY in the following intervals In a pre meal or fasting state more than 2 hours since the last me...

Страница 5: ...testing is a good thing Just remember any time you want to be sure of an accurate up to date blood glucose reading test on your fingertip 1 2 Low or high blood glucose readings can indicate a potentia...

Страница 6: ...know Self moni toring of blood glucose SMBG is a necessary part of the treatment plan for people with diabetes mellitus The Diabetes Control and Complications Trial DCCT has confirmed the significant...

Страница 7: ...on mode Test port This is where you insert the Test Strip into the Meter Battery Cover Label Reset Button Press this button to re set the system Glucode Chip Insert the Glucode Chip for coding Data po...

Страница 8: ...n the meter is ready for test Error Symbol Appears when the strip or meter error Day Average Symbol Shows the average value of test results from the last 7 14 or 30 days Test Result Area Display test...

Страница 9: ...n be used only once Code Number Control Solution Range Lot Number Expiration Date VIAL LABEL TEST STRIP VIAL About the TysonBio SUPERB Test Strip About the TysonBio SUPERB Test Strip Vial 13 14 3 1 2...

Страница 10: ...Meter will show a warning signal When this display appears it is time to replace a new battery When the low battery warning signal is shown the TysonBio SUPERB Meter will provide accurate results for...

Страница 11: ...ter and proceed with the following instructions M S To enter the day and move on to choose the hour setting press the M button To change the hour press the S button To enter the hour and move on to ch...

Страница 12: ...ig 3 10 11 12 To set the fourth alarm press the M button y If you press S button n it will move to health management alarm setting step 11 To change the hour press S button To enter the hour and move...

Страница 13: ...etting RESET 19 Checking the Performance of Your TysonBio SUPERB Meter The Glucode Chip is used for checking and coding your TysonBio SUPERB Meter To Check your Meter 1 2 Insert the Glucode Chip into...

Страница 14: ...test strip vial All segments of the LCD display will appear indicating that the TysonBio SUPERB Meter is functioning prop erly Then a beep will sound followed by the code number 1 2 Note If you are us...

Страница 15: ...d first into the test port The TysonBio SUPERB Meter will turn on automatically All segments of the LCD display will appear indicating that the TysonBio SUPERB Meter is functioning properly A beep wil...

Страница 16: ...test result will appear Caution Please remember that in order to prevent contamination follow the above instructions for perform ing the Control Solution test mg dL AM mg dL Comparing Control Solutio...

Страница 17: ...nd lancing device 1 2 3 4 Wash hands using soap and warm water Rinse and dry thoroughly Pull out a TysonBio SUPERB Test Strip from the vial and re cap the vial immediately Insert the Test Strip white...

Страница 18: ...m the lancing device Discard the used lancet properly in accordance with local state and federal law 1 2 3 4 5 6 7 8 After obtaining a blood sample place the drop onto the test well of the TysonBio SU...

Страница 19: ...er tests are performed the TysonBio SUPERB Meter will shut off automatically after 4 minutes After finishing the test we recommend using a tissue paper to remove TysonBio SUPERB Test Strip from the Ty...

Страница 20: ...can use your meter with TysonBio Link Health Management Software to transfer test results to your personal computer Obtain the required software and cable For order information please call Tyson Biore...

Страница 21: ...ient please be aware that all items that come in contact with human blood should be handled as potential biohazards Users should follow the guidelines for prevention of blood borne transmittable disea...

Страница 22: ...your physician immediately mg dL DISPLAY WHAT IT MEANS ACTION The TysonBio SUPERB Meter detects blood glucose level is lower than 20 mg dL 1 1 mmol L Temperature is too low to perform the test Temper...

Страница 23: ...icating a problem with the coding of TysonBio SUPERB Meter An error message indicating a problem with the TysonBio SUPERB Meter Indicate the result is HIGHER than the HI alarm setting of the health ma...

Страница 24: ...ed in the memory have been shown Press S or M button or wait for 4 minutes to turn off the meter DISPLAY WHAT IT MEANS ACTION Other problems that may occur ACTION The TysonBio SUPERB Test Strip has no...

Страница 25: ...tative in the EU EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Authorized representative in the EU Medical Device Safety Service GmbH Schiffgraben 41 D 30175 Hannover Germany TEL 49 5...

Страница 26: ...rocedure Caution The TysonBio SUPERB System is designed for in vitro use only and is not intended to test on newborns The TysonBio SUPERB Test Strips are designed for use with fresh capillary whole bl...

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